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Clinical Research Coordinator
3 mesi fa
This
part time role (24 hours per week) with an immediate start for about 4-6 months will be supporting one to two sites in
Milan, Italy in conducting clinical trials.
As a pivotal member of the site team, you will be involved with a variety of administrative tasks to support investigators and ensure the smooth running of clinical trials and assist with collecting patient data.
- Coordinate clinical research studies and maintain a safe study environment according to health and safety policies under the direction and delegation of the Principal Investigator
- Maintain uptodate study protocols, case report forms (CRFs), Electronic Data Capture (EDC) systems, and other study documents
- Plan and coordinate logístical activity for study procedures according to the study protocol
- Perform clinical setup and preparation for the study including labeling specimen collection tubes and containers, inventory of required supplies, and setting up or troubleshooting equipment and/or study issues
- Perform ECGs, spirometry, collect vital signs
- Prepare & Dispense Investigational product (IP) including its accountability (no IP administration)
- Collect, process and ship lab samples
- Assist with data entry, data quality checking, and query resolution to ensure adherence to study protocol and quality control for content accuracy and completeness
- Assist in study enrollment by recruiting, screening, and orienting volunteers according to the study protocol
- Correct custody of study drug according to site standard operating procedures
- Collect, record, and report clinical data and findings appropriately in CRFs while collaborating with study investigator about studyrelated adverse events and serious adverse events according to the study protocol
- Coordinate with study monitor on study issues and effectively respond to monitorinitiated questions.
- BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting, e.g. clinical research coordinator, nurse, medical assistant, other medical profession
- Medical/clinical background and skills to perform ECG, take vital signs etc
- Basic knowledge of clinical trials, combined with indepth knowledge of departmental, protocol and studyspecific operating procedures, consent forms, and study schedules
- Basic knowledge of medical terminology
- Excellent interpersonal skills with the ability to establish and maintain effective working relationships with coworkers, managers and client
- Good organizational skills with the ability to pay close attention to detail.
- Fluent English and Italian language skills